Regarding the U.S. Military/NIAID-Sponsored RV144 ALVAC/AIDSVAX "Prime-Boost" Vaccine Trial in Thailand By Richard Jefferys September 28, 2004 On September 23, 2004, the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee held a hearing to discuss the…
The Difference Between Drugs and New Drugs By Rob Camp August 2004 FDA announced approvals in early August of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. FDCs are…
In early August, FDA announced approvals of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents in the treatment of HIV-1 infection: GlaxoSmithKline's Epzicom® (abacavir/lamivudine) and Gilead Sciences, Inc.'s Truvada® (tenofovir disoproxil/emtricitabine).
July 2004 By Tracy Swan & Daniel Raymond INTRODUCTION TAG’s Hepatitis C and HIV/HCV Coinfection Report is a comprehensive review of basic and clinical science accompanied by recommendations for research and policy. It was written for people living with hepatitis…
By Rob Camp Edited by Jen Curry AIDS Treatment Activists Coalition (ATAC) On Tuesday, May 25, 2004, the National Institutes of Health (NIH) hosted a public meeting to seek comment from invited individuals, organizations, and other stakeholders on the use…
Debra B Birnkrant, MD Center for Drug Evaluation and Research Office of New Drugs Division of Anti-Viral Products (HFD-530) CRPII/Rm. N414 Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 Fax: 301.827.2523 Dear Dr Birnkrant, I am…
Regardless of HIV status, transplant candidates face a daunting shortage of livers "The organ shortage is a crucial problem. We need to keep working to expand the donor pool. I see people dying because they can't get organs." by Tracy…
February 2004 By Rob Camp Not so fast! Where's my pipeline? Pipelines are almost as delicate and fragile as the ecosystems they go trampling through. Oft times the way to get from the beginning to the end is not a…
And speaking of boosting… By Rob Camp and Heidi Nass December 2003 Executive Summary FDA granted accelerated approval to Agenerase® brand amprenavir (NDA 21-007 and NDA 21-039) in April 1999. 908 allows us an opportunity to get an easier-to-use drug…